關於促性腺激素釋放激素安全性的最新資訊 Latest safety update on gonadotropin-releasing hormone(GnRH) agonists

      美國食物及藥物管理局正評估使用促性腺激素釋放激素(gonadotropin-releasing hormone(GnRH) agonists)治療的前列腺癌男性病人, 其罹患糖尿病和某些心血管疾病(心臟病發﹑突然性心血管死亡﹑中風)的風險是否可能增加。USFDA正進行相關的回顧性研究, 目前並未作出任何關於GnRH激動劑的結論, 包括在使用這些藥物治療的前列腺癌病人中, 是否增加糖尿病及心血管疾病的風險。現時, USFDA對衛生專業人士作出下列建議:

  • 衛生專業人士應留意上述可能發生的安全性問題, 當採取治療方案時, 應謹慎衡量使用GnRH激動劑的效益和風險。
  • 應對接受GnRH激動劑的病人作出監測, 以確認有否罹患糖尿病和心血管疾病。
  • 醫生應按照現行的臨床實踐準則, 對病人作心血管危險因子的評估, 包括吸烟以及血壓﹑膽固醇﹑血糖和體重的升高。
  • 提醒病人除非醫生建議, 否則不應停止GnRH激動劑的治療。

     The United States Food and Drug Administration(USFDA) is evaluating whether Gonadotropin-Releasing Hormone (GnRH) Agonists may increase the risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer. USFDA's review is ongoing. The agency has not made any conclusions about GnRH agonists and whether they increase the risk of diabetes and cardiovascular disease in patients receiving these medications for prostate cancer. At this time, USFDA recommends healthcare professionals that:

  • Healthcare professionals should be aware of these potential safety issues and carefully weigh the benefits and risks of GnRH agonists when determining treatment.
  • Patients receiving GnRH agonists should be monitored for development of diabetes and cardiovascular disease.
  • Physicians should manage cardiovascular risk factors for patients, such as smoking and increases in blood pressure, cholesterol, blood sugar, and weight, according to current clinical practice.
  • Physicians should remind patients not to stop their treatment with GnRH agonists unless recommended by their attending physician.

 

參考資料/Reference and website:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm210576.htm

https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm209842.htm


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